Kornimate/medical-research-clean huggingface dataset:
hymovis™ versus placebo in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: purpose: the purpose of this study is to demonstrate if the intra-articular injection of a new viscoelastic hydrogel (hymovis) is superior to placebo (phosphate buffered saline \[pbs\] in subjects with symptomatic osteoarthritis of the knee.


Eligibility criteria:
inclusion criteria: 1. male or female ambulant outpatients ≥ 40 years of age with an active lifestyle: 2. has a medical history of oa symptoms confirmed at least 3 months prior to the screening visit with radiographic evidence of oa, kellgren-lawrence grade 2-3 3. discontinuation of any analgesic/nsaid therapy prior to baseline with no intent to resume during study exclusion criteria: 1. clinically significant apparent large effusion of the target knee; 2. clinically significant valgus/varus deformities, ligamentous laxity or meniscal instability as assessed by the investigator; 3. any musculoskeletal condition affecting the target knee that would impair assessment of the effectiveness in the target knee such as paget's disease 4. medical history of anaphylactic reactions 5. history of septic arthritis in any joint 6. females who are pregnant or breast-feeding

Keywords: osteoarthritis knee hyaluronan hyaluronic acid viscoelastic hydrogel
neural bases of multiple forms of self-regulatory control in bulimia nervosa

Conditions: Bulimia Nervosa

Summary: the purpose of this study is to investigate areas of the brain responsible for self-regulation in adult women who have never had an eating disorder with women who have bulimia nervosa. more specifically, investigators are interested in changes in brain activation (e.g., changes in blood flow and oxygen use) when inhibiting responses and regulating emotions. data collection will rely on a technology called functional magnetic resonance imaging (fmri).


Eligibility criteria:
general inclusion criteria: * female * right-handed * between the ages of 18 and 35 years \*for women with bulimia nervosa: * binge eating (i.e., eating a large amount of food while experiencing a sense of loss of control) * purging via self-induced vomiting (other methods may also be endorsed) general exclusion criteria: * current significant medical illness or condition (e.g., diabetes, thyroid disease) * pregnancy, planned pregnancy, or lactation during the study period * non-removable metallic objects in the body

Keywords: bulimia nervosa bulimia fmri emotion regulation response inhibition
investigation of kritech efficacy on subjects having functional discomfort associated to joints and muscles disorders

Conditions: Pain

Summary: joints and muscles disorders are common symptoms in the population. they are characterized by swelling, pain, functional impairment and morning stiffness. these disorders can be really disabling and painful, affecting the person's quality life. the purpose of this clinical trial is to test kritech (krill oil) efficacy in reducing these symptoms in 154 subjects complaining functional discomfort associated to joints and muscles disorders.

epidemiological studies on prevalence and incidence of joints and muscles disorders are scares. two epidemiological french studies recorded patients consulting their gp for widespread pain, whatever the cause. the most often cited pain localization was the musculoskeletal system (36-59% of the cases). in europe the situation is similar, with arthritis and osteoarthritis representing the 42% of pains. according to the who (world health organization) the musculoskeletal system's disorders are the first cause of handicap in the worldwide population. krill oil is low in both saturated fatty acids and monounsaturated fatty acid and high in polyunsaturated fatty acid including a high proportion of (n-3) fatty acids and particularly epa and dha. there are strong evidences that krill oil may improve the comfort of sensitive joints thank to its n-3 fatty acids and phospholipids content. particularly, after a supplementation with a dietary product containing pure krill oil, a reduction of systemic inflammation, trough reduction of crp, was concomitantly accompanied by improvement of various clinical scores associated with joint flexibility, comfort and function. despite this, there are no studies yet on healthy volunteers complaining the symptoms of rheumatologic pathologies, without being ill. here we performed a clinical trial on 154 subjects complaining functional discomfort associated to joints and muscles disorders. the principal objective was to test kritech efficacy in reducing these symptoms. subjects were split in two groups, with one receiving kritech and the second one the placebo for 12 weeks.

Eligibility criteria:
inclusion criteria: * male and female subjects; * \>18 years old; * complaining functional discomfort associated to joints and/or muscles disorders, motility disorders and/or initial smfa score higher or equal to 15 ; * able to give a written or verbal informed consent, * affiliated or beneficiary of social security exclusion criteria: * imc\>30kg/m * acute or chronic, progressive joint disorders (arthrosis, rheumatoid arthritis, acute articular rheumatism) of first or second degree and correlated treatments; * subjects refusing of giving their written or verbal informed consent * subjects deprived of freedom following an administrative or judicial decision * participation to another clinical trial in the last four weeks; * people who already participated to another research that comprises an exclusion period still ongoing at the time of inclusion

Keywords: inflammation swell pain functional impairment stiffness
a pilot study evaluating the signs and symptoms of seasonal allergic rhinoconjunctivitis following exposure in the allergen biocube

Conditions: Allergic Rhinoconjunctivitis

Summary: the objective of this study is to evaluate ocular and nasal signs and symptoms in patients with seasonal allergic rhinoconjunctivitis following allergen exposure in the allergen biocube.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * if female, cannot be pregnant or nursing; * have a history of ocular and nasal allergy and a positive skin test reaction to one of the allergens tested within the past 24 months; exclusion criteria: * have a history of mild persistent, moderate or severe asthma within the preceding 5 years according to the national heart, blood and lung institute classification; * have a compromised lung function; * have any ocular condition that could affect the subject's health or the study parameters; * have any presence of active ocular or sinus infection; * have significant nasal conditions; * have any significant illness that could be expected to interfere with the subject's health or with the study parameters * use specified disallowed medications (topical, topical ophthalmic, systemic and/or injectable treatments and all anti-allergy therapies) during the study or appropriate pre-study washout period; * have used an investigational drug or device within 30 days of starting the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study;

Keywords: allergic rhinitis allergic conjunctivitis
impact of antimicrobial stewardship on outcomes of patients with hospital-acquired pneumonia due to gram-negative bacilli - a before-after study

Conditions: Hospital-acquired Pneumonia

Summary: hospital-acquired pneumonia (hap) is one of the most frequent complications and the main cause of antibiotics use in hospitalized patients, particularly in intensive care units (icus). the latest european and french recommendations for the management of hap were published in 2017 and 2018. gram-negative bacilli are frequently identified in this pneumonia. the experts discussed the issue of tailored-empiric antimicrobial therapy. because delayed antimicrobial therapy is associated with poor outcomes, their conclusion was to reduce the time to deliver proper antimicrobial therapy, but to limit over-use of broad-spectrum molecules. since delays in microbiological identification hinder the ability of clinicians to streamline therapy, rapid diagnostic with multiplex pcr, which decreases the time to organism identification by 2 days compared to conventional methods, is appealing, especially for gram-negative bacilli. the filmarray® lower respiratory tract infection panel is a rapid multiplex pcr which tests for the most frequently pathogens (18 bacteria including plenty of gram-negative bacilli +5 genes of resistance, and 9 viruses) involved in hap. the filmarray® lower respiratory tract infection (lrti) panel has a sensitivity and a specificity of 95% and 99% respectively and can be implemented in a personalized antimicrobial guidance to treat hap due to gram-negative bacilli. the investigators hypothesized that a rapid multiplex pcr for guidance of empiric antimicrobial therapy, especially for gram-negative bacilli, reduces the time-to-proper antimicrobial therapy and reduces the risk of death of patients suffering of hap. the investigators aim to assess the efficacy of an antimicrobial stewardship including the results of a rapid respiratory panel multiplex pcr for empiric antimicrobial guidance in patients with hospital-acquired pneumonia due to gram-negative bacilli. the investigators will use a before-after design to test the efficiency of an antimicrobial stewardship including a highly innovative intervention.


Eligibility criteria:
inclusion criteria: * immunocompetent adult patients * receiving mechanical ventilation * suspected hospital-acquired pneumonia * non-opposition from the patient or a relative. exclusion criteria: * pregnant women, breastfeeding-women * minors, adults under guardianship or trusteeship
elimination of co2-insufflation-induced hypercarbia in open heart surgery

Conditions: Adult Patients Undergoing Open Heart Replacement of the Aortic Valve for Aortic Stenosis or Insufficiency

Summary: the study aim was to evaluate if an additional separate venous reservoir eliminates co2-insufflation induced hypercapnia and keeps sweep gas flow of the oxygenator constant during open heart surgery.

background: co2-gas insufflation is used for continuous de-airing during open heart surgery. the study aim was to evaluate if an additional separate venous reservoir eliminates co2-insufflation induced hypercapnea and keeps sweep gas flow of the oxygenator constant. methods: a separate small reservoir are used during cpb in addition to a standard large venous reservoir. the small reservoir receive drained wound blood and co2-gas continuously via a suction drain (1 l/min) and handheld suction devices from the open surgical wound. co2-gas is insufflated via a gas-diffuser in the open surgical wound at 10 l/min. during cross-clamping, gas and blood are either continuously drained to the standard large venous reservoir or not, every 5 minutes after steady state of paco2 is observed, after adjustment of sweep gas flow as necessary. mean values for each setup (2-4 times) for each patient will be analyzed with wilcoxon rank-sum test.

Eligibility criteria:
inclusion criteria: * adult patients undergoing open heart replacement of the aortic valve * use of perioperative cardiopulmonary bypass exclusion criteria: * denied participation in the study
developing and implementing a quality measure for glycemic control

Conditions: Diabetes

Summary: many patients with diabetes are under sub-optimal glycemic control. central to the clinician's task in improving glycemic control is the management of hypoglycemic medication therapy, including the use of drugs such as insulin and sulfonylureas. clinical trials have demonstrated that more intensive hypoglycemic medication therapy results in improved glycemic control. yet quality measures for this critical process of care have not been developed and we know little about how physicians actually manage hypoglycemic medications.

background: many patients with diabetes are under sub-optimal glycemic control. central to the clinician's task in improving glycemic control is the management of hypoglycemic medication therapy, including the use of drugs such as insulin and sulfonylureas. clinical trials have demonstrated that more intensive hypoglycemic medication therapy results in improved glycemic control. yet quality measures for this critical process of care have not been developed and we know little about how physicians actually manage hypoglycemic medications. objectives: we propose to develop a quality measure that describes the intensity of physicians' hypoglycemic medication therapy. we will then provide feedback to va physicians regarding their practices and access to experts in diabetes care to determine whether this intervention leads to improvements in glycemic control. methods: the study was divided into two phases. during the first phase we used existing data to model the decision to increase hypoglycemic medications. at each medical visit, we determined whether an increase in medication therapy occurred. we then used recursive partitioning to develop a model that identified patient characteristics at the visit, such as recent laboratory results and diagnoses, associated with the decision to increase therapy. this model assigns a predicted probability of an increase in therapy to each visit. we used these predictions to define an intensity of hypoglycemic medication therapy for each physician that compared the actual to predicted number of increases over all patient-visits. the second phase was a randomized trial in which clinicians at experimental sites receive feedback on performance and access to expert opinion while usual care is provided at control sites. feedback on performance was provided twice over 6 months. the change in intensity of treatment scores and glycosylated hemoglobin levels pre- and post-intervention at these sites were compared to performance of primary care physicians at control sites not receiving the intervention. status: completed.

Eligibility criteria:
inclusion criteria: clinic patients with diabetes exclusion criteria:
place of comprehensive geriatric assessment in patients ≥ 75 years care, with breast cancer, after screening with fog (oncology geriatric filter)

Conditions: Surgery; 75 Years Old and More; Female Breast Cancer

Summary: the risk of diagnosis of cancer increases with age, especially breast cancer in elderly women. elderly population is heterogeneous, regarding physiological reserves, comorbidities, disability and geriatric conditions. comprehensive geriatric assessment (cga) is a multidimensional approach to determine geriatric profile, in helping the therapeutic strategy. in-patients with diagnosis of cancer are screened with the fog (oncology geriatric filter), to identify vulnerable subjects who may benefit from cga. this scale of ten questions includes geriatric domains such as functional status, nutrition, mood, cognitive abilities and comorbidities. in elderly patients with breast cancer considered as fit (fog=0), cga is not necessary before adjuvant treatment. in vulnerable patients (fog ≤ 1 and \< 3), cga is held in routine to discuss the adjuvant therapy feasibility. patients with fog ≥ 4 underwent cga if palliative care is considered. patients in the intermediate group (fog 1-3) are randomized to determine time of cga, before or after surgery. the aims of this study are to assess the outcomes regarding the time of cga, in elderly female patients with breast cancer management, and to define the optimal place of cga in care pathway.


Eligibility criteria:
inclusion criteria: * first breast cancer localized, indication of surgery * onco-geriatric filter (fog) \>= 1 ou \< 4 exclusion criteria: * male, less of 75 years old * contraindication of surgery * breast cancer with metastasis * onco-geriatric filter (fog) = 0 or 4

Keywords: breastcancer standardized geriatric evaluation onco-geriatric filter
olfactogustatory perception, eating behaviour and inflammation in crohn's disease

Conditions: Crohn's Disease; Olfactogustatory Perception

Summary: this study will improve our understanding of the mechanisms underlying anorexia in persons with crohn's disease flare-ups. the practical spin-off from this research is potentially very important for the management of nutritional disorders associated with the disease by guiding diets towards foods that correspond to patients' preferences and/or to modified tastes. in addition, the results could lead to the identification of sensory markers that herald an inflammatory flare-up of the disease.


Eligibility criteria:
for patients : inclusion criteria: * age between 18 and 60 years, * diagnosis of crohn's disease according to clinical, endoscopic, histological, radiological and biochemical criteria as defined by the european consensus conference, * men or women who have provided consent and willing to cooperate. exclusion criteria: * chronic inflammatory intestinal disease (ciid) other than crohn's disease: haemorrhagic rectocolitis, undetermined colitis, microscopic colitis. * intercurrent disease (diabetes and metabolic disease, liver cirrhosis, progressive cancer, acute or chronic infection, human immunodeficiency virus hiv), * organ failure (respiratory, heart, or renal failure, neurological disorders), * intolerance to gluten, * treatments (other than those used for crohn's disease) able to interfere with food intake, * aversion to foods consumed or smelled, * poor understanding of cognitive tasks required. * crohn's disease complicated by an abscess or infectious complication * acute crohn's disease defined by a cdai score \> 150 for controls: inclusion criteria: * adult person * without follow-up for a chronic pathology * having given its consent exclusion criteria: * protected adult * person not affiliated to a social security system * pregnant or breastfeeding woman * active smoker * no one who does not speak french * taking treatment that interferes with taste or acts on the central nervous system
clitoral therapy device in alleviating sexual dysfunction after genital mutilation.

Conditions: Sexual Dysfunction; Sexual Arousal Disorder

Summary: the aim of this study to determine the effect of clitoral therapy device eros device/ on sexual dysfunction after genital mutilation.

little attention has been given to women who exposed to genital mutilation surgery in early age in the middle east. most of them suffer from sexual dysfunction of sexual arousal and orgasm when they get in an intimate relation with their husbands after marriage. clitoral therapy device may improve sexual arousal and alleviate sexual dysfunction symptoms to a great extent.

Eligibility criteria:
inclusion criteria: * all are suffering sexual dysfunction of sexual arousal and all referred from the family planning and reproductive health department, national research center. exclusion criteria: * metastatic disease, severe bowel or bladder sequelae, and significant comorbidities. women with a history of sexual trauma or abuse, or undergoing current antidepressant therapy were excluded.

Keywords: sexual arousal disorder
dyspnea and biomarkers in a prehospital setting

Conditions: Dyspnea; Heart Failure; Asthma; COPD

Summary: in patients presenting with acute dyspnea in a pre-hospital setting, the early and correct diagnosis may present a significant clinical challenge. physical examination, chest radiography, electrocardiography, and standard biological tests often fail to accurately differentiate heart failure (hf) from pulmonary causes of dyspnea. timely differentiation of hf from other causes of dyspnea may permit the early institution of appropriate medical therapy. brain natriuretic peptide (bnp) and amino-terminal pro-brain natriuretic peptide (nt-probnp) have been proposed as early markers of hf and demonstrated to be useful for diagnosing and excluding hf in the emergency department. a combination of bnp or nt-probnp testing and standard clinical assessment has been suggested to be superior to either tool used in isolation. some previous studies have also suggested that quantitative capnometry (qc) may be useful in differentiating between cardiac and obstructive causes of respiratory distress. therefore, the investigators hypothesized that a new combination of nt-probnp testing, standard clinical assessment, and partial pressure of end-tidal co2 (petco2) would optimize evaluation and differentiation of acute dyspnea in a pre-hospital setting. the aim of this study was to determine the accuracy of combination of qc, nt-probnp, and clinical assessment in differentiating acute hf from obstructive pulmonary disease (copd/asthma) as a cause of acute dyspnea in pre-hospital emergency setting.


Eligibility criteria:
inclusion criteria: * patient had to present with shortness of breath as the primary complaint (defined as either the sudden onset of dyspnea without history of chronic dyspnea or an increase in the severity of chronic dyspnea) exclusion criteria: * age \<18 years * history of renal insufficiency, trauma, severe coronary ischemia (unless patient's predominant presentation was dyspnea), and other causes of dyspnea: * pneumonia * pulmonary embolism * carcinoma * pneumothorax * pleural effusion * intoxications (drugs) * anaphylactic reactions * upper airway obstruction * bronchial stenosis * gastroesophageal reflux disorder * according to the history, clinical status, and additional laboratory tests available in pre-hospital setting (d-dimer, troponin, c-reactive protein)

Keywords: quantitative capnometry n-terminal pro-brain natriuretic peptide acute heart failure diagnostic accuracy